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Interoceptive Engagement

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT03583060
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed project is the first pilot test to examine interoceptive function as a mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an empirically-validated and manualized protocol is explicitly designed to teach interoceptive awareness skills for emotion regulation and is thus an ideal intervention approach in which to address this gap in research. This study uses a two group, randomized design to examine neural and physiological biomarkers in response to MABT. Twenty-four individuals reporting moderate stress will be recruited from the community and randomized to 8-week MABT intervention or the control condition. The study aims are to: 1) evaluate whether interoceptive training improves interoceptive function in the MABT vs control condition, and 2) explore whether changes in interoceptive function correlate with improved health outcomes. Analyses will include within and between-group ANOVA of brain activity with symptom change as a covariate. This is the first study to test whether a clinical intervention aimed specifically at cultivating interoceptive awareness effects change on interoceptive biomarkers. The results will support larger NIH proposals to more comprehensively validate neuro and behavioral biomarkers of interoceptive training to enhance mental health, particularly targeting depression and substance use disorder that have identified interoceptive dysfunction and poor emotion regulation.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindful Awareness in body-oriented therapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Interoceptive Engagement in Response to Mindful Awareness in Body-oriented Therapy: A Pilot Test Comparison
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: MABT

Receive 8 weekly sessions of Mindful Awareness in Body-oriented Therapy (MABT).

Behavioral: Mindful Awareness in body-oriented therapy
teaches interoceptive awareness skills for self care
No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. interoceptive function [10 weeks]

    Functional magnetic resonance imaging (fMRI)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • adult (over 18)

  • Perceived Stress Scale scores indicating moderate stress levels

  • naive to mindfulness-based approaches (no prior experience)

  • agrees to forgo (non-study) manual therapies (e.g., massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test)

  • fluent in English

  • can attend MABT and assessment sessions

  • right-handed (for uniformity of neuroimaging results)

Exclusion Criteria:

  • lifetime diagnosis of mental health disorder

  • unable to complete study participation (includes planned relocation, pending inpatient treatment, planned extensive surgical procedures, etc.)

  • cognitive impairment, assessed by the Mini-Mental Status Exam (MMSE) if demonstrated difficulty comprehending the consent

  • use of medications in the past 30 days that affect hemodynamic response

  • lifetime head injuries or loss of consciousness longer than 5 min

  • currently pregnant

  • contraindications for MRI, e.g., claustrophobia, metal objects in body, etc.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington

Investigators

  • Principal Investigator: Cynthia Price, PhD, University of Washington
  • Principal Investigator: Norman Farb, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cynthia Price, Research Assoc. Professor, University of Washington
ClinicalTrials.gov Identifier:
NCT03583060
Other Study ID Numbers:
  • STUDY00003441
First Posted:
Jul 11, 2018
Last Update Posted:
May 13, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 13, 2020